Without limiting the scope of the invention, its background is described in connection with vaccine development.
Protein engineering technology relating to monoclonal antibodies is highly advanced regarding humanization (i.e., rendering e.g., a rodent mAb sequence into a human mAb sequence while preserving specific antigen combining sites of the original mAb) and production (typically secreted from mammalian cell lines). In research and development are new applications of rAbs related to vaccination and are presently based on engineered rAb-antigen fusion proteins (typically with the antigen coding region placed in-frame with the C-terminal codon of the rAb heavy or H chain). A roadblock to this technology is the successful expression and production of fully functional rAb-antigen. In many, perhaps most, cases the desired antigen confounds secretion of the engineered rAb-antigen. Also, the likelihood of poor or null expression is increased if the desired entity includes multiple antigen coding regions.